Hub for positioning annular structure on a surgical device

ABSTRACT

An apparatus for forming an anastomosis between adjacent intestinal sections is provided. The apparatus includes an anastomosis device having a cartridge assembly; and an anvil assembly having a shaft extending therefrom and a connection feature on the shaft. The apparatus further including a hub having a connection portion selectively attachable to the connection feature of the shaft, the connection portion defining a lumen for receiving the shaft; and an annular structure operatively connected to the hub and extending radially outwardly therefrom, the hub being arranged for locating the annular structure between the adjacent intestinal sections when connected to the shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Divisional Application of prior U.S. patentapplication Ser. No. 11/365,636, filed Feb. 28, 2006, the entire contentof which is incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to annular structures and devices forpositioning the same and, more particularly, to hubs for positioningannular structures, gaskets and the like for use in conjunction withcircular stapling devices, for reducing occurrences of leaking, bleedingand/or stricture.

2. Background of Related Art

Staples have traditionally been used to replace suturing when joining oranastomosing various body structures, such as, for example, the bowel orbronchus. The surgical stapling devices employed to apply these staplesare generally designed to simultaneously cut and seal an extendedsegment of tissue in a patient, thus vastly reducing the time and risksof such procedures.

Linear or annular surgical stapling devices are employed by surgeons tosequentially or simultaneously apply one or more linear rows of surgicalfasteners, e.g., staples or two-part fasteners, to body tissue for thepurpose of joining segments of body tissue together and/or for thecreation of anastomoses. Linear surgical stapling devices generallyinclude a pair of jaws or finger-like structures between which bodytissue to be joined is placed. When the surgical stapling device isactuated and/or “fired”, firing bars move longitudinally and contactstaple drive members in one of the jaws, and surgical staples are pushedthrough the body tissue and into/against an anvil in the opposite jawthereby crimping the staples closed. A knife blade may be provided tocut between the rows/lines of staples. Examples of such surgicalstapling devices are described in U.S. Pat. Nos. 4,354,628, 5,014,899and 5,040,715, the entirety of each of which is incorporated herein byreference.

Annular surgical stapling devices generally include an annular staplecartridge assembly including a plurality of annular rows of staples,typically two, an anvil assembly operatively associated with the annularcartridge assembly, and an annular blade disposed internal of the rowsof staples. Examples of such annular surgical stapling devices aredescribed in U.S. Pat. Nos. 5,799,857 and 5,915,616 to Robertson et al.,the entirety of each of which is incorporated herein by reference.

For most procedures, the use of bare staples, with the staples in directcontact with the patient's tissue, is generally acceptable. Theintegrity of the tissue will normally serve to prevent the staples fromtearing out of the tissue and compromising the sealing before healinghas occurred. However, in some surgical operations, surgical supports,e.g., meshes, are employed by surgeons to bridge, repair and/orreinforce tissue defects with a patient, especially those occurring inthe abdominal wall, chest wall, diaphragm and other musculo-aponeuroticareas of the body. Examples of surgical supports are disclosed in U.S.Pat. Nos. 3,054,406, 3,124,136, 4,347,847, 4,655,221, 4,838,884 and5,002,551, the entirety of each of which is incorporated herein byreference.

When the staples are applied in surgical procedures utilizing surgicalsupports (i.e., reinforcing material), the legs of the staple typicallypass from the cartridge jaw through a layer of the surgical support, andthrough the patient's tissue before encountering the anvil jaw. In analternative procedure, the legs of the staple typically pass from thecartridge jaw through a first layer of the surgical support, thenthrough the patient's tissue, and finally through a second layer of thesurgical support before encountering the anvil jaw. With the staples inplace, the stapled tissue is clamped between the layers of the surgicalsupport.

The surgical supports described above are used in conjunction withlinear surgical stapling devices. An end-to-end anastomosis stapler suchas a Model “EEA™” instrument is available from United States Surgical, aDivision of Tyco Health-Care Group, LP, Norwalk, Conn. and disclosed inU.S. Pat. No. 5,392,979 to Green et al. In general, an end-to-endanastomosis stapler typically places an array of staples into theapproximated sections of a patient's bowel or other tubular organs. Theresulting anastomosis contains an inverted section of bowel whichcontains numerous “B” shaped staples to maintain a secure connectionbetween the approximated sections of bowel.

In addition to the use of surgical staples, biological tissue adhesiveshave been developed for tissue repair and the creation of anastomoses.Generally, biological adhesives bond separated tissues together to aidin the healing process and to enhance the tissue strength. Suchadhesives may be used instead of suturing and stapling, for example, insurgical procedures, for the repair of tissue or the creation ofanastomoses.

In addition to the use of biological adhesives, following the formationof the anastomosis, a separate instrument or device is used to applybiological sealants to the anastomosis. Typically, in a separate step,the biological sealants are applied to the outer surface of theanastomosis by spraying on, brushing on, swabbing on, any combinationsthereof, or any other method contemplated by those skilled in the art.The biological sealants act to reduce and/or stop the incidents ofleakage from the anastomosis.

One possible side effect of any end-to-end bowel anastomosis is itstendency to stenos over time, which stenosis can decrease the diameterof the lumen over time. Accordingly, the need exists for a structurewhich assists in maintaining the lumen of the anastomosed bowel or othertubular organ open over time.

The application of a suitable biocompatible adhesive offers manyadvantages to the patient and the surgeon alike, such as, for example,the possible reduction in the number of staples used, immediate sealingof the tissue being treated, a strengthening of the anastomosis, and areduction in the occurrence of bleeding from the blood vessels, leakagethrough the tissue joint, and stricture. Moreover, use of biocompatibleadhesives tends to minimize foreign body reaction and scarring.

Accordingly, the need exists for devices for properly positioning astructure with respect to opposed tissue which has been transected.

SUMMARY

The present disclosure relates to hubs for positioning annular supportstructures, gaskets and the like on delivery devices, for reducingoccurrences of leaking, bleeding, stricture and other complications.

According to an aspect of the present disclosure, an apparatus forforming an anastomosis between adjacent intestinal sections is provided.The apparatus includes an anastomosis device including an anvil assemblyhaving a shaft which is selectively attachable to a tubular bodyportion; and a hub for locating an annular structure between theadjacent intestinal sections. The hub includes a central sleeve defininga lumen for receiving the shaft of the anvil assembly therein. Thecentral sleeve forms a connection portion for engaging a feature on theanastomosis device and connecting the hub to the device. The apparatusfurther includes an annular structure operatively connected to thesleeve and extending radially outwardly therefrom.

According to another aspect of the present disclosure, an assembly fordisposing an annular structure between adjacent intestinal sections isprovided. The assembly includes an annular surgical stapling device,having an anvil assembly and a tubular body portion, the anvil assemblyhaving an anvil member and an anvil shaft, the tubular body portioncarrying a plurality of surgical staples in an annular configuration,the tubular body portion having a connection member disposed radiallyinward of the surgical staples, the anvil shaft of the anvil memberbeing attachable to the connection member of the tubular body. Theassembly further includes a hub including a central sleeve defining alumen therethrough for selectively receiving the anvil shaft therein,and an annular structure radially extending from the central sleeve,wherein when the center hub is positioned on the anvil shaft the supportstructure is concentrically located with respect to a longitudinal axisof the anvil shaft.

According to yet another aspect of the present disclosure, a method ofdisposing an annular structure between adjacent tissue sections isprovided. The method includes the steps of: a) providing a surgicalstapling device including an anvil assembly and a body portion, theanvil assembly including an anvil member supported on an anvil shaft andthe body portion carrying a plurality of surgical staples and a knife;b) providing a hub for locating a support structure between the adjacenttissue sections, the hub including a central sleeve defining a lumenwhich is configured and adapted for selectively receiving the shaft ofthe anvil assembly therein, and an annular structure operativelyconnected to the central sleeve and extending radially outwardlytherefrom; c) inserting the anvil assembly into a first tissue section;and d) positioning the hub onto the anvil shaft such that the annularstructure is concentrically located with respect to a longitudinal axisof the anvil shaft and such that the annular structure is positionedadjacent to the first tissue section.

The method further includes the steps of: a) inserting the body portionin a second tissue section; b) approximating the anvil assembly and bodyportion with one another so that an end portion of the first tissuesection, an end portion of the second tissue section and the annularstructure are disposed between the anvil member and the body portion,wherein the annular structure is disposed between the first tissuesection and the second tissue section; c) deploying the staples from thebody portion; and d) cutting the first tissue section, the second tissuesection, and the annular structure with the knife.

The hub may include an annular flange monolithically formed with andextending from the central sleeve. The flange may extend from a firstend of the central sleeve.

The central sleeve may include a plurality of longitudinally extendingslots formed around a periphery thereof. Each elongate slot may extendthrough one end of the central sleeve. The slots may be defined by aplurality of flexible fingers.

The annular structure may be fabricated from at least one of abioabsorbable and a non-bioabsorbable material. It is envisioned thatthe annular structure may include a material selected from the groupconsisting of an adhesive, a sealant, a hemostat, and a medicament.

The annular structure may include an outer annular disc defining acentral opening having a dimension larger than an outer diameter of thecentral sleeve, and a web interconnecting the disc to the centralsleeve.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given aboveand the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view of an exemplary annular surgical staplingdevice;

FIG. 2 is a perspective view of a hub according to an embodiment of thepresent disclosure for use with the surgical stapling device of FIG. 1;

FIG. 3 is a perspective view of the hub of FIG. 2 including an annularstructure operatively associated therewith;

FIG. 4 is a perspective view of the intestinal area of a patient,illustrating a method of using the annular surgical stapling device ofFIG. 1; and

FIG. 5 is an enlarged side elevational view of the anvil assembly ofFIG. 4, illustrating the hub of FIG. 3 positioned on the anvil rodthereof.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed center hub will now be describedin detail with reference to the drawing figures wherein like referencenumerals identify similar or identical elements. As used herein and asis traditional, the term “distal” refers to that portion which isfurthest from the user while the term “proximal” refers to that portionwhich is closest to the user.

Referring initially to FIG. 1, an annular surgical stapling device, foruse with the annular adhesive structures disclosed herein, is generallydesignated as 10. Surgical stapling device 10 includes a handle assembly12 having at least one pivotable actuating handle member 14, and anadvancing member 16. Extending from handle member 12, there is provideda tubular body portion 20 which may be constructed so as to have acurved shape along its length. Body portion 20 terminates in a staplecartridge assembly 22 which includes a pair of annular arrays of staplereceiving slots 36 having a staple (not shown) disposed in each one ofstaple receiving slots 36. The body portion 20 includes a connectionmember 40 extending distally therefrom. An anvil assembly 30 has ananvil member 26 and an anvil rod 28 operatively associated therewith.The anvil rod 28 removably connects anvil assembly 30 to connectionmember 40 so that the anvil assembly 30 is positioned distally of staplecartridge assembly 22 of stapling device 10.

Staple cartridge assembly 22 may be fixedly connected to the distal endof tubular body portion 20 or may be configured to concentrically fitwithin the distal end of tubular body portion 20. Typically, staplecartridge assembly 22 includes a staple pusher (not shown) including aproximal portion having a generally frusto-conical shape and a distalportion defining two concentric rings of peripherally spaced fingers(not shown), each one of which is received within a respective staplereceiving slot 36.

Typically, a knife (not shown), substantially in the form of an open cupwith the rim thereof defining a knife edge, is disposed within staplecartridge assembly 22 and mounted to a distal surface of the staplepusher (not shown). The knife edge is disposed radially inward of thepair of annular arrays of staples. Accordingly, in use, as the staplepusher is advanced, the knife is also advanced axially outward.

Reference may be made to U.S. Pat. No. 5,915,616 to Viola et al., theentire content of which is incorporated herein by reference, for adetailed discussion of annular stapling device 10.

Turning now to FIGS. 2 and 3, a hub 100, in accordance with anembodiment of the present disclosure, is shown and is described below.Hub 100 is intended to be used with stapling device 10, described above.Hub 100 is intended to locate and secure an annular structure 200relative to anvil rod 28 of anvil assembly 30.

As seen in FIGS. 2 and 3, hub 100 includes a central sleeve 102 defininga central lumen 104 and a longitudinal axis “X”. Hub 100 includes anannular flange 106 extending radially outwardly from a first end 102 aof central sleeve 102. As seen in FIGS. 2 and 3, flange 106 may beorthogonally oriented with respect to the longitudinal “X” axis. Flange106 is desirably monolithically formed with central sleeve 102. Centralsleeve 102 is configured and dimensioned to selectively receive anvilrod 28 of anvil assembly 30 therethrough.

Central sleeve 102 forms a connection portion for connecting to thesurgical stapling device 10. Central sleeve 102 includes a plurality oflongitudinally oriented elongate slots 108 formed therethrough. In anembodiment, each elongate slot 108 extends though a second end 102 b ofcentral sleeve 102. Elongate slots 108 define a plurality of fingers 110therebetween. As seen in FIGS. 2 and 3, each elongate slot 108 mayextend through first end 102 a of central sleeve 102. In this manner,each finger 110 is flexible and/or deflectable either radially inward orradially outward.

Hub 100 may be fabricated from a material suitably rigid so as toaccurately locate hub 100 relative to anvil shaft 28 of anvil assembly30 and suitably flexible so as to enable fingers 110 to deflect asneeded, in the manner described above. Additionally, hub 100 may befabricated from a material suitable for ethylene oxide (EtO) and/orgamma sterilization. Hub 100 may be fabricated from, and is not limitedto, acrylonitrile butadiene styrene (ABS), glass filled polypropylene orsome combination thereof. It is envisioned that hub 100 may be plasticinjection molded or manufactured from any other suitable method known byone having skill in the art, such as, for example, machining, stampingand/or the like.

With particular reference to FIG. 3, hub 100 is shown having an annularstructure 200 operatively associated therewith. Annular structure 200includes an outer circular disc 202 defining a central opening 202 a anda web 204 extending radially inward of central opening 202 a of disc 202and terminating in opening 204 a. In an embodiment, central opening 202a has a dimension which is larger than an outer diameter of flange 106of hub 100. As seen in FIG. 3, web 204 may extend from disc 202 toflange 106 of hub 100.

In an embodiment, disc 202 of annular structure 200 is sized such thatan outer edge 202 b thereof extends radially outward beyond stapleretaining pockets 36 of staple cartridge assembly 22. Additionally, disc202 of annular structure 200 is sized such that opening 204 a is sizedsuch that disc 202 extends radially inward beyond staple retainingpockets 36 of staple cartridge assembly 22.

It is contemplated that disc 202 of annular structure 200 may befabricated from or include a surgical grade, biocompatible,non-absorbable (i.e., permanent) material; desirably a mesh impregnatedwith an adhesive, sealant and/or wound treatment material. For example,disc 202 may be fabricated from “TEFLON”, which is a registeredtrademark owned by DuPont de Nemours & Co. It is further contemplatedthat disc 202 may be fabricated from a biocompatible polymeric foam,felt, polytetrafluoroethylene (ePTFE), gelatin, fabric or the like, orany other biocompatible material.

Non-absorbable materials used for disc 202 include, and are not limitedto, those that are fabricated from such polymers as polyethylene,polypropylene, nylon, polyethylene terephthalate,polytetrafluoroethylene, polyvinylidene fluoride, and the like. Furthernon-absorbable materials include and are not limited to stainless steel,titanium and the like.

In one embodiment, disc 202 of annular structure 200 may be fabricatedfrom a bio-absorbable material which is desirably impregnated with anadhesive, sealant, and/or other wound treatment material (e.g., amedicament). Accordingly, a sealant component of annular structure 200can be used to retard any bleeding which may occur from the tissue, anadhesive component of annular structure 200 can be used to secure theapproximated tissue together, and the bio-absorbability of annularstructure 200 allows for annular structure 200 to be absorbed into thebody after a predetermined amount of time. For example, annularstructure 200 may remain in place in the body for approximately 2-3weeks in order for the anastomosis to sufficiently heal prior to annularstructure 200 being absorbed into the body. In other embodiments,annular structure 200 has at least one portion that is absorbable and atleast one portion that is not absorbable.

Bio-absorbable materials used for disc 202 of annular structure 200include, and are not limited to, those fabricated from homopolymers,copolymers or blends obtained from one or more monomers selected fromthe group consisting of glycolide, glycolic acid, lactide, lactic acid,p-dioxanone, a-caprolactone and trimethylene carbonate. Otherbio-absorbable materials include and are not limited to, for example,Polyglycolic Acid (PGA) and Polylactic Acid (PLA). In one embodiment,disc 202 may be fabricated from bio-absorbable felt, ePTFE, gelatin orany other bio-absorbable materials.

It is contemplated that the adhesive is a biocompatible adhesiveincluding, but not limited to, adhesives which cure upon tissue contact,which cure upon exposure to ultraviolet (UV) light, which are two-partsystems which are kept isolated from one another and cure upon cominginto contact with one another, which are pressure sensitive, which areany combinations thereof, or any other known suitable adhesive. In oneembodiment, it is contemplated that an adhesive having a cure time offrom about 10 to 15 seconds may be used. In another embodiment, it iscontemplated that an adhesive having a cure time of about 30 seconds maybe used.

It is envisioned that disc 202 of annular structure 200 may beimpregnated with a pre-cured adhesive or sealant. The pre-cured sealantor adhesive will react with the moisture and/or heat of the body tissueto thereby activate the sealing and/or adhesive properties of thesealant or adhesive. It is envisioned that the pre-cured sealant oradhesive may be a hydro-gel or the like.

It is envisioned that the wound treatment material “W” includes and isnot limited to one or a combination of adhesives, hemostats, sealants,coagulants, astringents, and medicaments. Other surgically biocompatiblewound treatment materials “W” which may be employed in or applied bysurgical instruments, including surgical staplers, include adhesiveswhose function is to attach or hold organs, tissues or structures;sealants to prevent fluid leakage; hemostats to halt or preventbleeding; coagulants, astringents (e.g., sulfates of aluminum) andmedicaments. Examples of adhesives which can be employed include proteinderived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc.

The wound treatment material may include a cross-linking material and/orreactive agent that reacts with the support structure, tissue or both.The resulting material acts as a seal or tissue-joining material that isnon-absorbable. For example, the wound treatment material may be basedon biocompatible cross-linked polymers formed from water solubleprecursors having electrophilic and nucleophilic groups capable ofreacting and cross-linking in situ, including those disclosed in U.S.Pat. No. 6,566,406, the entire contents of which are incorporated hereinby reference.

The wound treatment material may be disposed on annular structure 200 orimpregnated into annular structure 200. Medicaments may include one ormore medically and/or surgically useful substances such as drugs,enzymes, growth factors, peptides, proteins, dyes, diagnostic agents orhemostasis agents, monoclonal antibodies, or any other pharmaceuticalused in the prevention of stenosis.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerin(e.g., 1,2,3-pranatetriol, also known as glycerol and glycerine)thereto. In this manner, the water and/or glycerin cure the adhesive andhydrate the wound.

It is further contemplated that wound treatment material “W” mayinclude, for example, compositions and/or compounds which accelerate orbeneficially modify the healing process when particles of thecomposition and/or compound are applied to or exposed to a surgicalrepair site. For example, the wound treatment material “W” may be atherapeutic agent which will be deposited at the repair site. Thetherapeutic agent can be chosen for its antimicrobial properties,capability for promoting repair or reconstruction and/or new tissuegrowth. Antimicrobial agents such as broad spectrum antibiotic(gentamycin sulfate, erythromycin or derivatized glycopeptides) whichare slowly released into the tissue can be applied in this manner to aidin combating clinical and sub-clinical infections in a tissue repairsite. To promote repair and/or tissue growth, wound treatment material“W” may include one or several growth promoting factors, e.g.,fibroblast growth factor, bone growth factor, epidermal growth factor,platelet derived growth factor, macrophage derived growth factor,alveolar derived growth factor, monocyte derived growth factor,magainin, and so forth. Some therapeutic indications are: glycerol withtissue or kidney plasminogen activator to cause thrombosis, superoxidedimutase to scavenge tissue damaging free radicals, tumor necrosisfactor for cancer therapy or colony stimulating factor and interferon,interleukin-2 or other lymphokine to enhance the immune system.

In one embodiment, it is contemplated that disc 202 of annular structure200 may be impregnated with a first component of a two-part adhesive andthat the device deploys the second component of the two-part adhesive.For example, in a surgical stapler 10, the staples, which are retainedin staple receiving slots 36 of staple cartridge assembly 22, may becoated with a second component (e.g., a reactant) of the two-partadhesive. In this manner, the first component of the adhesive isactivated when the staples penetrate and capture disc 202 of annularstructure 200 during the firing sequence of surgical stapling device 10,and the two components of the adhesive contact one another.

It is further envisioned that annular structure 200 may include a singlelayered disc 202 including a homogeneous array of bio-absorbable ornon-absorbable materials or a heterogeneous array of bio-absorbableand/or non-absorbable materials. In certain embodiments, disc 202 may beimpregnated with a pressure sensitive adhesive which is activated whenadjacent layers of tissue are approximated, with disc 202 disposedtherebetween.

In an alternate embodiment, it is contemplated that annular structure200 may include a layered body portion having at least two layers. Inthis embodiment, each layer may include a homogeneous or heterogeneousarray of bio-absorbable and/or non-absorbable materials. It isenvisioned that each layer may be separated from one another prior tothe surgical procedure. In certain embodiments, the annular structure200 includes the structures disclosed in U.S. patent application Ser.Nos. 11/241,267 and 11/248,846, the disclosures of which are herebyincorporated by reference herein in their entirety.

With continued reference to FIG. 3, web 204 may be fabricated from anysuitable mesh or the like. As seen in FIG. 3, web 204 of annularstructure 200 is secured to flange 106 of hub 100 in such a manner thatdisc 202 is concentric with central sleeve 102 and with the longitudinal“X” axis.

Turning now to FIGS. 4 and 5, there is illustrated the use of surgicalstapling device 10 and hub 100 in an anastomosis procedure to effectjoining of intestinal sections 66 and 68. The anastomosis procedure istypically performed using minimally invasive surgical techniquesincluding laparoscopic means and instrumentation. At the point in theprocedure shown in FIG. 4, a diseased intestinal section has beenpreviously removed, anvil assembly 30 has been introduced to theoperative site either through a surgical incision or trans-anally andpositioned within intestinal section 68, and tubular body portion 20 ofsurgical stapling device 10 has been inserted trans-anally intointestinal section 66. Intestinal sections 66 and 68 are also showntemporarily secured about their respective components (e.g., shaft 28 ofanvil assembly 30, and the distal end of tubular body portion 20) byconventional means such as a purse string suture “P”.

As seen in FIG. 5, hub 100 is attached onto shaft 28 of anvil assembly30, prior to the coupling of anvil assembly 30 to the distal end oftubular body portion 20, and either before or after the anvil assemblyis secured to intestinal section 68. In particular, shaft 28 of anvilassembly 30 is inserted through first end 102 a of central sleeve 102into lumen 104 of central sleeve 102. In this position, annularstructure 200 is located adjacent intestinal section 68. Followingpositioning of hub 100 onto shaft 28 of anvil assembly 30, the surgeonmaneuvers anvil assembly 30 until the proximal end of shaft 28 isconnected to connection member 40 of surgical stapling device 10,wherein the mounting structure (not shown) engages shaft 28 to effectthe connection. As shown in FIG. 5, the shaft 28 of the anvil assembly30 has a feature, such as a protrusion or recess or flange 101, forengagement by hub 100. The fingers 110 are desirably flexible to assistthe hub 100 and annular structure 200 onto shaft 28. In otherembodiments, a shaft associated with the body portion 20 has a featurefor engagement by the hub 100.

Thereafter, while ensuring disc 202 of annular structure 200 isextending radially outward, anvil assembly 30 and tubular body portion20 are approximated to approximate intestinal sections 66, 68 andcapture disc 202 of annular structure 200 therebetween. With disc 202 ofannular structure 200 captured between intestinal sections 66, 68,surgical stapling device 10 may be fired thereby stapling intestinalsections 66, 68 to one another, securing disc 202 of annular structure200 between intestinal section 66, 68, and cutting the portion of tissueand annular structure 200 disposed radially inward of the knife, tocomplete the anastomosis.

Hub 100 is removed from the surgical site upon withdrawal of surgicalstapling device 10 from the surgical site. The hub 100 locates theannular structure 200 on the surgical stapling device 10 so that it ispositioned at the desired location with respect to the portions oftissue being joined. The procedure is simplified in that the annularstructure 200 may not need to be positioned on shaft 28 inside thepatients body.

It will be understood that various modifications may be made to theembodiments of the presently disclosed surgical stapling apparatus andthe various dispensing systems and methods described above. For example,the hub and annular structure may be used on a surgical device forpositioning the annular structure, that does not deploy staples. Suchsurgical devices may incorporate a wound treatment material dispensingapparatus. Therefore, the above description should not be construed aslimiting, but merely as exemplifications of preferred embodiments. Thoseskilled in the art will envision other modifications within the scopeand spirit of the present disclosure.

1. A method of disposing an annular structure between adjacent tissuesections, the method comprising the steps of: a) providing a surgicalstapling device including an anvil assembly and a body portion, theanvil assembly including an anvil member supported on an anvil shaft andthe body portion carrying a plurality of surgical staples and a knife;b) providing a hub for locating an annular structure between theadjacent tissue sections, the hub including a central sleeve defining alumen which is configured and adapted for selectively receiving theshaft of the anvil assembly therein, and an annular structureoperatively connected to the central sleeve and extending radiallyoutwardly therefrom; c) inserting the anvil assembly into a first tissuesection; and d) positioning the hub onto the anvil shaft such that theannular structure is concentrically located with respect to alongitudinal axis of the anvil shaft and such that the annular structureis positioned adjacent to the first tissue section.
 2. The methodaccording to claim 1, further comprising the steps of: a) inserting thebody portion in a second tissue section; b) approximating the anvilassembly and body portion with one another so that an end portion of thefirst tissue section, an end portion of the second tissue section andthe annular structure are disposed between the anvil member and the bodyportion, wherein the annular structure is disposed between the firsttissue section and the second tissue section; c) deploying the staplesfrom the body portion; and d) cutting the first tissue section, thesecond tissue section, and the annular structure with the knife.
 3. Themethod according to claim 1, wherein the hub includes an annular flangemonolithically formed with and extending from the central sleeve.
 4. Themethod according to claim 3, wherein the flange extends from a first endof the central sleeve.
 5. The method according to claim 1, wherein thecentral sleeve includes a plurality of longitudinally extending slotsformed around a periphery thereof.
 6. The method according to claim 5,wherein each elongate slot extends through one end of the centralsleeve.
 7. The method according to claim 1, wherein the annularstructure is fabricated from at least one of a bioabsorbable or anon-absorbable material.
 8. The method according to claim 7, wherein theannular structure comprises a material selected from the groupconsisting of an adhesive, a sealant, a hemostat, and a medicament. 9.The method according to claim 1, wherein the annular structure includesan outer annular disc defining a central opening having a dimensionlarger than an outer diameter of the central sleeve, and a webinterconnecting the disc to the central sleeve.
 10. A method ofutilizing a disc with a surgical stapler for joining and reinforcingtissue, the method comprising the steps of: providing a surgical staplerincluding an anvil assembly and a body portion, the anvil assemblyincluding an anvil member operably associated with an anvil rod, theanvil rod including a protrusion disposed about an outer portionthereof; fixedly positioning a hub onto the anvil rod, the hub includinga sleeve configured to receive the anvil rod and a disc extendingradially outward from the sleeve, wherein the sleeve of the hub engagesthe protrusion of the anvil rod at a location to position the disc inaxial spaced relation from a tissue contacting surface of the anvilmember; and coupling the anvil rod of the anvil assembly with the bodyportion such that the disc is disposed in spaced relation from a tissuecontacting surface of the body portion.
 11. The method of claim 10,further comprising the step of securing a first tissue to the anvilassembly at a location between the tissue contacting surface of theanvil assembly and the disc of the hub.
 12. The method of claim 10,further comprising the step of securing a second tissue to the bodyportion at a location between the tissue contacting surface of the bodyportion and the disc of the hub.
 13. The method of claim 11, furthercomprising the steps of: securing a second tissue to the body portion;and approximating the anvil assembly and the body portion such that thedisc of the hub is captured between the first and second tissues. 14.The method of claim 10, further comprising the step of firing thesurgical stapler to deploy staples from the body portion and to form thestaples against the anvil member.
 15. The method of claim 10, whereinthe sleeve of the hub includes elongated axially extending slotsdefining a plurality of resilient fingers, wherein the resilient fingerssnap over the protrusion of the anvil rod when the hub is positioned onthe anvil rod.
 16. The method of claim 10, wherein the hub includes aweb extending radially inward from the disc and interconnects the discwith the sleeve of the hub.
 17. The method of claim 16, wherein the stepof approximating the anvil assembly and the body portion furtherincludes step of cutting the web to release the disc from the sleeve ofthe hub.
 18. The method of claim 17, wherein the step of approximatingthe anvil assembly and the body portion further includes the step offiring a knife to cut the web of the hub.